Clinical Contract Manager :

Description:

Job Description:

Job Title: Clinical Contract Manager

Job ID: BIIBJP00009821

Location: Cambridge, MA or RTP, NC (Can work either at Cambridge or RTP)

Duration: 6 Months

Position Summary

The CCM will support the outsourcing and contracting needs of global clinical development Phase I – IV programs. With responsibility for the end to end contracting process (including but not limited to validating requirements, leading competitive multi-vendor Request for Proposals, evaluating budget’s competitiveness, negotiating, building and executing statements of work and managing change orders). The CCM executes a best in class approach to vendor outsourcing and contracting for their assigned service categories of central lab, patient recruitment and retention, patient travel, site equipment, site training/portal, home health and others.

Responsibilities

• Lead vendor evaluation and selection process through Request for Proposals (RFP)

• Lead the vendor outsourcing (analysis of bid/budget responses)

• Act as the primary contact with vendors for negotiation of the scope of work, study assumptions and budget on behalf of the study team

• Previous experience with vendor contracts in central lab, patient recruitment and retention, patient travel, site equipment, site training/portal and home health is ideal.

Operational & Technical Skillset:

• Project management skills, including ability to handle a large volume of complex tasks and prioritize effectively

• Strong financial negotiation skills

• Ability to successfully implement change management and lead others through change

• Broad knowledge of the clinical development process (Pharma R&D and Clinical) with a clear understanding of operational and quality (GCP) aspects

• Computer proficiency in a Windows environment (e.g., MS Project, Excel, Word, PowerPoint, Visio, and Outlook), as well as ERP systems is a plus (for systems-based planning functionality), with aptitude to learn new systems

Must Haves:

1. Minimum of 3+ years’ experience in the pharmaceutical/biotechnology industry in a clinical vendor management/outsourcing role

2. Experience with end to end contracting process (including but not limited to validating requirements, leading competitive multi-vendor Request for Proposals, evaluating budget’s competitiveness, negotiating, building and executing statements of work and managing change orders)

3. Previous experience with vendor contracts in central lab, patient recruitment and retention, patient travel, site equipment, site training/portal and home health is ideal.